Italian Propulsid warnings "ineffective"

16 April 2001

Doctors in Italy continued to prescribe Janssen's gastroesophageal drugPropulsid (cisapride) in potentially dangerous combinations with other drugs, even after the company had warned against this, says a report in the April 11 issue of the Journal of the American Medical Association.

In June 1998, the drug's label was changed and Janssen wrote to doctors in Italy warning of the dangers of using it in patients with conditions such as congestive heart failure and chronic obstructive pulmonary disease, and of potentially dangerous interactions with some antibiotics, antidepressants and certain other drugs. However, by November 1999, about 8% of Italian patients being treated with Propulsid were still also receiving other drugs included in the warnings, which was about the same percentage as before the warnings were issued, say the researchers, Roberto Raschetti et al at the Istituto Superiore di Sanita in Rome.

Janssen voluntarily withdrew Propulsid from the US market on July 14, 2000, due to serious cardiovascular events associated with its use (Marketletter April 3, 2000). In Italy, its use is now restricted to hospital use and certain patients only.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK





Today's issue

Company Spotlight